Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

Obesity Clinical Trial

— SAVIOR  

Official title:

The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02461433
• Other study ID #: IRB00030337
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: February 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.

Description:

In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.

The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.

• Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.

• Patient with BMI= 30 at the time of surgery

• Patient agrees to return for all required clinical follow up for the study.

Exclusion Criteria:

• Known allergic reaction to acrylic adhesives or silver.

• Known history of intolerance to any component of Prevena Incision Management System TM.

• Very fragile skin around incision site.

• Bleeding disorder or refuses blood transfusion.

• Malignancy or other condition limiting life expectancy to <5 years.

• Pregnancy

Related Conditions & MeSH terms

• Obesity
• Postoperative Complications
• Surgical Wound Infection
• Wound Infection
• Wound Infection, Surgical
• Wounds and Injuries

Intervention

Device:
• Prevena
Prevena Incision Management system
• Standard Dressing
This involves standard of care dressing including but not limited to gauze.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutes	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Kinetic Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines	The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery	Up to 7 days postop
Secondary	Other Wound Complications (Aggregate)	Dehiscence, seroma and hematoma. Reported as number of aggregate events.	Up to 14 days postop
Secondary	Skin Bacterial Count as Assessed by Microbacterial Count	Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count	Up to 7 days postop
Secondary	Physical Function as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Secondary	Readmissions	Readmission events for the patients.	Up to 30 days postop
Secondary	Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Secondary	Social Functioning as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Secondary	Energy / Fatigue as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Secondary	Emotional Well Being as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Secondary	Pain as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop
Secondary	General Health as Assessed by Short Form Survey (SF) 36	The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 14 days postop